Oto Ease by Westone — Class II medical device recall Z-2058-2012
Terminated recall by Westone Laboratories, Inc., reported 2012-08-01, distributed nationwide. Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential mic
| Recall number | Z-2058-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Westone Laboratories, Inc., Colorado Springs, CO, United States |
| Recall initiated | 2012-07-13 |
| Classified | 2012-07-20 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2012-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, DE, FR, GB, GR, HK, IE, JP, KR, MX, PA, PH, SE, SG, TH |
| Reason classes | microbial contamination |
Product
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
Reason for recall
Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2058-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.